Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

April 30, 2006

Grand Jury Is Investigating Ex-Chief of FDA

Associated Press

NEW YORK, April 29 -- The former commissioner of the Food and Drug Administration is under federal investigation amid accusations of financial improprieties and making false statements to Congress, a newspaper reported Saturday.

The New York Times, citing Lester M. Crawford's attorney, Barbara Van Gelder, said a grand jury has begun a criminal investigation of Crawford. She declined further comment.

Van Gelder told a federal magistrate in a telephone hearing Thursday that she would instruct Crawford to invoke his Fifth Amendment right against self-incrimination if ordered to answer questions about his actions as head of the FDA, a transcript of the hearing shows.

Crawford did not reply to messages left by the Times seeking comment. FDA spokeswoman Kathleen Quinn also declined to comment. A message left at Van Gelder's Washington office was not immediately returned.

Crawford resigned in September, two months after the Senate confirmed him, saying it was time for someone else to lead the agency. He had been acting commissioner for more than a year.

SRI scientists to test anthrax

Birmingham NewsDAVE PARKS, News staff writer

Lab renovated to safely handle bioterror agents

Southern Research Institute's high-security lab in Birmingham is undergoing a major renovation that will allow it to attract millions of dollars in new projects and perform research into the one of the most lethal bioterror agents, aerosolized anthrax.

The lab was closed in November and is expected to reopen in July with new safety equipment and modifications that will allow scientists to work on pathogens such as anthrax sprayed into the air, said Tina Rogers, vice president of the institute's Drug Development Division.

The million-dollar-plus renovation is being paid for by Southern Research and the National Institute of Allergy and Infectious Diseases. When completed, the upgraded lab could attract up to $42 million in work over the next seven years, according to government estimates.

Rogers said the renovation will allow the lab to handle research into aerosolized anthrax, the most dangerous form of the bacteria. Once aerosolized, anthrax spores cannot be seen by the naked eye or smelled.

But they can be inhaled and lodge in lungs, where they spread throughout the body and produce deadly toxins. This type of inhalation anthrax is the most fatal form of the disease.

In 2001, a series of anthrax attacks occurred in the United States. The substance was sent by mail, and victims developed inhalation anthrax. Five people died.

Southern Research's 13-year-old, 10,000-square-foot Biosafety Level 3 facility is one notch below a top-of-the-line BSL 4 lab, like the one at the Centers for Disease Control in Atlanta.

Labs on rise

The federal government has been increasing the nation's BSL 3 and BSL 4 capacity so more research can be conducted on biological warfare agents and emerging diseases.

The University of Alabama at Birmingham is building a BSL 3 lab, which has raised safety concerns. The new UAB lab and the renovated Southern Research lab both will be working with deadly microbes in the heavily populated Medical District.

Debra Sharpe, safety and security manager for Southern Research, said there is no reason for public concern about the anthrax research. "The facility's safe, and the community's safe," she said.

She said safety standards at Southern Research labs are better than those found in most labs. For instance, workers in Southern Research's lab wear respirators. That's not done in all BSL 3 labs, she said.

In addition, workers are upgrading Southern Research's lab with new and redundant safety systems, things such as two new pressure doors for its sterilization area. The large stainless steel doors costs $65,000 each, Sharpe said. "But they're pretty cool, because you can crank them down and nothing comes out."

Most important, a new mini-lab is being created within the main lab. This one-room lab is for research into aerosolized agents and contains two large, stainless steel glove boxes. The mini-lab is fitted with a $200,000 autoclave.

The safety of the main lab and mini-lab is maintained by negative air pressure and filters. Air is constantly pulled into lab space and filtered, preventing microbes from escaping. "It's not the walls that make you safe," Sharpe explained. "It's directional air flow."

Rogers said the renovations will allow Southern Research to conduct more studies of pathogens such as anthrax in compliance with the FDA Good Laboratory Practice regulations. Southern Research will be one of the few companies in the United States that will meet these standards in a BSL 3 lab, Rogers said. "That's really a unique capability."

The standard is necessary to test drugs when human clinical trials aren't possible. For example, the practices would be followed when testing animals with a vaccine to protect them against anthrax. It would be impossible to conduct such studies on humans since it would require infecting them with anthrax.

An anthrax vaccine exists. But it requires multiple shots over a long time, and there are concerns about side effects.

Anthrax error in 2004 revealed lab problems

The Birmingham NewsDAVE PARKS, News staff writer

An anthrax mistake two years involving Southern Research Institute revealed gaps in the nation's system of regulating labs, and an activist organization says a comprehensive lab safety law is badly needed.

The problem occurred in 2004 when Southern Research's lab in Frederick, Md., shipped anthrax spores that were supposed to be inactivated to Children's Hospital Oakland Research Institute in California for vaccine studies.

Lab animals started dying, and scientists found that the spores were still active. Nobody became ill, but the mistake sparked an investigation by the Centers for Disease Control.

The CDC found a flaw in the process used by lab workers in Frederick to inactivate anthrax spores. And they found that lab workers in Frederick failed to test cultures to ensure that the anthrax was deactivated.

Debra Sharpe, safety and security manager for Southern Research, said the process has been corrected, and safety oversight has been increased.

Procedures for inactivating anthrax or any other pathogens are now reviewed by the company's institutional biosafety committee, which oversees labs in Birmingham and Frederick, and by the CDC, she said.

But there are no laws requiring such oversight, Sharpe said. Institutional biosafety committees, which are supposed to be a cornerstone of lab safety, grew years ago out of concern about genetic engineering. They are based upon guidelines from the National Institutes of Health, which require that these committees oversee government-funded research involving recombinant DNA technology.

But the committees are not required to oversee other research, including so-called "dual use" research - legitimate scientific work with agents such as anthrax that could be misused. A government committee, the National Science Advisory Board for Biosecurity, has been meeting on the issue.

Edward Hammond, director of the U.S. office of the activist organization Sunshine Project, said the Board for Biosecurity is moving too slowly, and the nation needs stronger laws regulating lab safety, something that is being resisted by many scientists.

"We have a sort of fuzzy system," he said.

There are too many vague regulations and too much secrecy surrounding research into bioterror agents, Hammond said. Taxpayers are spending billions of dollars for this research, he said, and they have a right to know what's being done and the dangers to the community.

The CDC refuses to release specific information about which labs are performing this sensitive research. The information is exempt from the Freedom of Information Act, said Von Roebuck, a CDC spokesman. "It's a security measure."

Under NIH guidelines, minutes from institutional biosafety committee meetings are public information. But Southern Research and other labs have determined that only minutes involving recombinant DNA technology have to be made public.

Sharpe said there is no law or guideline requiring full disclosure, and minutes pertaining to bioterror research include proprietary information.

Sharpe said Southern Research is open about the kind of work it's doing.

"I don't want some black cloak around what we do," she said. "We don't feel like we have anything to hide."

Sharpe agreed that a comprehensive lab safety law would clarify things, but it would be controversial. "I think it's a lot of control and a lot of Big Brother, but I believe we ought to do that."

Indonesians Love Chicken, Bird Flu Scare or Not

As Others Panic, Citizens Accept Life With Virus and Do Not Alter Their Diet

By Alan SipressWashington Post Foreign Service

JAKARTA, Indonesia -- Here at the heart of the epidemic, where bird flu continues to rip through poultry flocks and more people now succumb to the virus than anyplace else on Earth, the lunchtime crowd at the Ayam Goreng Suharti restaurant can't get enough of the chicken.

The ravenous and the merely peckish cram nearly every one of the two dozen tables. They hunch over their plates, tearing off chunks of the succulent meat with their hands, licking their greasy fingers. While international health experts continue to sound the alarm about the prospect of pandemic and U.S. officials warn ominously that the disease could appear in American birds by fall, the overriding concerns at this Jakarta eatery turn on whether to order the chicken fried or grilled, with chili or spices; to have half a bird or to splurge on a whole one.

Indonesians have learned after two years to live with bird flu. Their now-sober response offers a lesson in levelheadedness to those abroad who are panicked or might soon be.

The initial scare over the mysterious new ailment faded in Indonesia as deaths became routine -- an average of almost one a week now. The virus proved exceptionally hard to catch, even for those who work closely with birds. Restaurants and butchers reported a recovery in their sales, and voracious Jakartans continue to crowd into food stalls along the roadsides, sheltered from the sun and exhaust fumes by large tarps adorned with cartoon chickens cheerfully advertising the house specialty.

"The bird flu cases don't affect us," said Elitha Tambunan, 38, nudging aside her plate, now bare but for a pile of stripped bones. "We're assured the chicken here is of the highest quality. It's a matter of trust."

Despite a tropical downpour hammering the roof and flooding the parking lot, Tambunan had ventured across the capital with two fellow office workers for a leisurely lunch at Ayam Goreng Suharti, part of a popular national chain. By the end of the day, the restaurant would go through about 300 chickens, all butchered on the premises. A pair of letters from animal health officials taped to the front door attested to their health.

Tri Warsono, 39, a stocky man with a long, slender mustache, was picking at the last scraps with his fingertips. "I'm not worried. I don't come here that often, but I eat chicken almost every day at my house," he said, dipping his fingers in a small water bowl to clean them. "Chicken is always on the menu in an Indonesian home."

Since avian influenza was first confirmed in Indonesian poultry at the start of 2004, the disease has struck flocks in two-thirds of the country's provinces, killing millions of birds. Government efforts to contain the outbreak have stumbled, with agriculture officials now acknowledging they cannot afford to pay for a national poultry vaccination program initially scheduled to begin next month.

The virus is also taking a mounting human toll. At least 32 Indonesians have contracted the disease since the initial human infection was confirmed in the middle of last year, and two-thirds have died. Though Vietnam still ranks first in overall cases, the disease has this year turned deadlier in Indonesia than at anywhere else. Yet the total number remains trifling.

"People here are coming to realize that most of us are not at great risk of getting the virus," said Steven Bjorge of the World Health Organization's office in Jakarta. "People are figuring out that on a day-to-day basis, this is not a real threat."

In Europe, where the virus was confirmed in wild birds across the continent this year, the consumption of chicken and eggs immediately tumbled. The discovery of a single dead swan infected with bird flu in Scotland this month sent Britain into a tizzy. The British media went on a war footing and callers flooded animal health hotlines with suspected sightings of sick birds, a likely preview of the American response should migratory fowl carry the disease to the West Coast as predicted.

Panic has also swept Egypt, where people responded by turning off their tap water after television stations broadcast news that infected carcasses were being dumped by farmers into the Nile River. In India, a farmers group reported this month that seven peasants had committed suicide after the disease destroyed their livelihoods.

In Indonesia, however, the issue of bird flu has all but vanished from the front pages of the newspapers. Peddlers hawking spicy chicken soup with coconut milk from pushcarts boast of a brisk business.

The U.S.-based restaurant chain KFC, which operates 242 outlets across the archipelago, recorded a slight decline in sales when bird flu was first reported two years ago, but they rebounded within a week, according to Adi S. Tjahjadi, customer relations manager. A colorful poster at the entrance to the KFC restaurant across from his office reads: "Eating chicken and eggs that was perfectly cooked is not dangerous. Remember, being alert is not being afraid." It informs customers of the precautions taken to properly prepare the chicken. But few who visit the restaurant allow themselves to note the details.

Indonesians have already surmised what researchers demonstrated in findings published last month: It's awfully tough to catch bird flu. Two teams of scientists found that the virus has trouble attaching to human cells in the nose, throat and upper airway, making infection unlikely.

Bjorge and other influenza specialists warn that the real danger would arise if the virus mutated into a new form easily passed from one person to the next. That could spark a global outbreak, killing millions in a matter of months.

At the Jatinegara market, a heavyset woman with a sweat-soaked T-shirt named Yulianti reported that sales from her chicken counter had dropped by half when the first Indonesian died from the virus in July. But they bounced back within two months.

"The media coverage of the first bird flu cases really blew them up big. Then it died down, so the people came back," said Yulianti, 30, with a broad smile, wiping her forehead with a rag as she peddled feet and livers off the tile countertop. "Indonesians have become resilient because the cases are such a regular thing."

Around her, shoppers strolled the muddy tile floors of the indoor market, perusing odd bits and pieces of chicken in the twilight of a few naked bulbs dangling from the high ceiling. Some recalled swearing off chicken for the first two weeks until the Indonesian government issued assurances that poultry properly cooked at more than 160 degrees was safe to eat.

Others, like Diah Febriantiene, 32, who was lugging three whole chickens and the innards of a fourth in a plastic bag, said she never stopped buying poultry. "My son won't eat fish," she said.

Public fears over bird flu have been overtaken by the anxieties of daily life in Indonesia: the doubling of fuel prices last year, recurring outbreaks of dengue fever, a food scare prompted by illicit use of formaldehyde as a preservative, floods, landslides and, in recent days, the threat of volcanic eruption. Other diseases, such as malaria and tuberculosis, have continued to claim far more casualties than bird flu has.

Nor are poultry deaths anything new. Most Indonesians grow up with chickens and are accustomed to seeing them fall over from mysterious causes each rainy season. Across an alley from the Jatinegara chicken market, some of the old-time butchers suggested the Indonesian government had concocted the story of bird flu to distract people from economic hardship.

"People don't really believe you eat chicken and then you die," said Nashirin, 50, a skinny butcher whose frequent smile revealed a set of crooked teeth. "They've been eating chicken forever, and they just keep doing what they've been doing."

His words were interrupted by the defiant cackling of scores of chickens awaiting their fate in dirty cages fashioned from bamboo and wire mesh. Several butchers, some barefoot and wearing only shorts, were squatting among the pools of blood, hacking apart the carcasses and untangling their insides with bare hands.

"There's no reason to worry about bird flu," said Mohamed Nur, 42, a burly man with a soiled green T-shirt and blood-splattered pants. "Not only don't we die, we don't even get sick. And we cut up chickens every day."

April 28, 2006

Ex-Head of F.D.A. Faces Criminal Inquiry

New York TimesBy GARDINER HARRIS

Dr. Lester M. Crawford, the former commissioner of food and drugs, is under criminal investigation by a federal grand jury over accusations of financial improprieties and false statements to Congress, his lawyer said Friday.

The lawyer, Barbara Van Gelder, would not discuss the accusations further. In a court hearing held by telephone on Thursday, she told a federal magistrate that she would instruct Dr. Crawford to invoke his Fifth Amendment right against compelled self-incrimination if ordered to answer questions this week about his actions as head of the Food and Drug Administration, according to a transcript of the hearing.

Dr. Crawford did not reply to messages seeking comment, and Kathleen Quinn, an F.D.A. spokeswoman, declined to comment.

Dr. Crawford resigned in September, fewer than three months after the Senate confirmed him. He said then that it was time for someone else to lead the agency.

The next month, financial disclosure forms released by the Department of Health and Human Services showed that in 2004 either Dr. Crawford or his wife, Catherine, had sold shares in companies regulated by the agency when he was its deputy commissioner and acting commissioner. He has since joined a Washington lobbying firm, Policy Directions Inc. The criminal investigation was disclosed at a court hearing in a lawsuit over the F.D.A.'s actions on the emergency contraceptive Plan B, a subjectof bitter contention during Dr. Crawford's tenure as acting commissioner and commissioner. After the pill's maker, Barr Laboratories, applied three years ago to sell the pill over the counter, the agency repeatedly delayed making a decision on the application.

While many lawmakers, abortion rights advocates and former F.D.A. officials said the delays had resulted from politics, Dr. Crawford and other agency officials said their concerns were scientific and legal.

An advocacy group, the Center for Reproductive Rights, sued the agency in federal court in New York over the delays. Many such suits are quickly dismissed, but a federal judge allowed the case to proceed, giving the center the right to interview top F.D.A. officials, including Dr. Crawford. Dr. Crawford was scheduled to be questioned under oath on Thursday, but on Wednesday Ms. Van Gelder, who is his personal lawyer, asked for a delay, saying she would instruct him to invoke his Fifth Amendment rights. Dr. Crawford previously declined to answer questions from the Government Accountability Office about Plan B.

Ms. Van Gelder told Magistrate Judge Viktor V. Pohorelsky of the District Court for the Eastern District of New York on Thursday that Dr. Crawford had been represented by Justice Department lawyers in the reproductive rights center's suit.

According to the transcript, she said that Dr. Crawford was under criminal investigation and that the issue of his financial disclosures "is within the grand jury."

Before Dr. Crawford's confirmation, the secretary of health and human services, Michael O. Leavitt, promised that the F.D.A. would act on the Plan B application by September 2005, a promise that led two Democratic senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, to relent in their efforts to delay the nomination. But after he was confirmed, Dr. Crawford announced an indefinite delay that has remained in effect.

Simon Heller, a lawyer for the reproductive rights center, noted that the F.D.A. had long insisted that its actions regarding Plan B were not unusual. "It would be remarkable if the Justice Department was conducting a criminal investigation of Plan B and at the same time asserting in a civil case that everything done was normal," Mr. Heller said.

City Plans for Phase II of Avian Flu Preparation

By Meghan StreitMedill News Service

(Medill News Service) CHICAGO The second phase of preparation for the possibility for an avian flu pandemic will officially begin in Chicago this fall.

Phase II will focus on family preparedness and continuity of government and business in the event of an outbreak. Phase I preparation began last September and was partly funded by a $1.2 million federal grant.

The 2006 federal appropriation for nationwide avian flu preparation is $350 million, according to Christine Kosmos, deputy commissioner for the Chicago Dept. of Public Health. Kosmos said she hopes the funding for phase II will exceed the initial federal grant.

Kosmos and other officials at a Union Club panel discussion on Thursday emphasized the importance of pandemic preparation at the local level. Kosmos said if a massive flu outbreak occurs, Chicago agencies may not be able to turn to state and national government for assistance, as they typically would in an emergency.

"We should not plan on getting lots of resources from somewhere else because everyone will be in the same boat," Kosmos said. "We need our own supplies, our own staffing plans, and we need to make sure our residents are as prepared as they can be."

Ginny Nareste, public information officer for the U.S. Environmental Protection Agency, said about 90 percent of emergencies are handled by local first-responders, such as police and fire departments.

An avian flu pandemic is inevitable, according to Dr. Michelle Watters, regional emergency coordinator for the Office of Public Health Emergency Preparedness for the Department of Health and Human Services.

"We don't know what the timing will be, so the question is, 'What do you do for planning?'" Watters said.

The panel experts disputed the claim that unnecessary hysteria has been created around the avian flu, saying a possible pandemic is not like anthrax or mad cow disease -- past scares that never escalated to the levels initially anticipated.

"You have a history of influenza," Watters said. "It occurs and it is naturally evolving."

Public health experts said the Spanish flu killed up to 40 million people in 1917-1918. The Asian flu claimed one to two million lives from 1957-1958, and the Hong Kong flu of 1968-1969 caused one million deaths.

Watters said one of the key concerns is vaccine development. She said there is a production shortage of regular influenza vaccine, causing heightened concerns about the nation's ability to produce an adequate supply of avian flu vaccine.

There are currently 20 million anti-viral treatment doses to combat avian flu in the national stockpile, Watters said. The goal is to make 81 million doses available by the end of 2008. Treatment involves taking two pills per day for five days.

Another focus of the phase II preparation is getting businesses ready for a potential pandemic. Mike Rice, a Union Club health and sciences committee member, said that if an avian flu pandemic hit the U.S., the economic impact would be a loss $675 billion. Another impact would be that people who contract the illness, which could be 30 percent of the U.S. population, would out of the workforce for about three weeks.

Watters said that local business owners need to start discussing the possibility of an avian flu pandemic with their management teams and making plans to keep their companies running in the event of an outbreak.

Kosmos said some issues companies should start discussing are human resources policies about extended sick leave and shift and work-at-home arrangements. The measures include making sure bathrooms are stocked with soap and signs reminding employees to wash hands, and disaster recovery plans to deal with events like a supplier going out of business or a key executive getting sick.

Kosmos said also that some businesses may have to work with their competitors to draft emergency plans, and consider merging resources to stay in business during a pandemic.

Kosmos said families should prepare for the pandemic by stockpiling food, water and medication, gathering emergency contact information, and visiting informational websites like alertchicago.com.

"It's more like a Katrina than anything else we will ever plan for," Kosmos said.

Watters stressed that the avian flu in its current form is still a bird flu. She said people who contracted the disease were in very close contact with infected birds. Nevertheless, she said she thinks preparation for a future pandemic is extremely important.

"The more we prepare people up-front. . .the less I think there will be hysteria," Kosmos said.

April 26, 2006

Vaccine is first treatment for Ebola-like virus

ReutersBy Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - A vaccine that protects monkeys against the highly deadly Marburg virus, a relative of Ebola, may also provide the first known treatment for the infection, researchers reported on Wednesday.

Now they hope to use a similar vaccine to try to treat Ebola. Both viruses have caused rare, but frightening and deadly, outbreaks in Africa and both are considered to be potential bioterror agents.

The vaccine was created using a harmless virus known as vesicular stomatitis virus, or VSV. The researchers took out one gene and replaced it with a key gene from Marburg virus.

When they infected monkeys with Marburg and then administered the vaccine, the monkeys were protected and stayed healthy, said Thomas Geisbert of the U.S. Army Medical Research Institute of Infectious Diseases.

Unvaccinated monkeys died within 10 to 12 days.

"We were very surprised," Geisbert said.

Geisbert, whose team worked with colleagues at the National Microbiology Laboratory at the Public Health Agency of Canada, published the findings in this week's issue of the Lancet medical journal.

He said it may be a while before the vaccine is tested in people but hopes it is a first step.

Marburg virus killed more than 300 people -- 90 percent of those infected -- in Angola last year. Ebola is usually somewhat less deadly and killed 254 people between 2001 and 2005 in Gabon and the Democratic Republic of Congo.

There is no cure for either diseases, both caused by a family of viruses known as filoviruses. They lead to a particularly nasty form of hemorrhagic fever and victims usually die of multiple organ failure and shock.

WORST-CASE SCENARIO

A few victims have been lab or medical workers experimenting with the virus or trying to help patients who suffered "needle-stick" accidents that tend to infect the victim with a large dose of virus.

"In the 1976 Ebola outbreak in former Zaire (now the Democratic Republic of Congo) there were 85 confirmed needle sticks because they were re-using needles. All 85 folks died that got stuck with a needle and the disease course went faster," Geisbert said in a telephone interview.

"In a real-world situation most folks are going to be exposed to much lower doses of virus by different routes."

If the vaccine was so effective in monkeys given high doses of virus, it should be effective in an outbreak scenario in which people typically get lower doses, Geisbert said.

Close contact is needed to transmit both Ebola and Marburg. Geisbert said relatives preparing a victim for burial often become infected, possibly through infected blood getting into small cuts or abrasions, or by touching blood or other bodily fluids and then touching the nose, mouth, lips or even eyes.

It may take some time to develop and license a human vaccine, but Geisbert said it may be possible to use an experimental version in case of a lab accident.

It is not certain whether a similar vaccine against Ebola will be as effective because of small but significant differences between the viruses, Geisbert said.

He also said Wyeth was testing a similar vaccine approach for the AIDS virus.

Experimental vaccine protects nonhuman primates when given after exposure to Marburg virus

US Army Medical Research Institute of Infectious Diseases; andPublic Health Agency of Canada

A team of U.S. and Canadian scientists has demonstrated the effectiveness of a vaccine in preventing the development of hemorrhagic fever in an animal model after exposure to the deadly Marburg virus. Their findings, published in the April 27 online edition of the British medical journal The Lancet, could have implications for human use.

Marburg virus was first detected in 1967 and was the cause of a large outbreak in Angola in 2004-2005 that resulted in several hundred deaths with case fatality rates of about 90 percent. Like the Ebola virus, Marburg is a filovirus that causes internal bleeding at multiple sites with patients usually dying as a result of multiple organ failure. Both viruses are considered to be potential agents of bioterrorism. Currently, no effective vaccines or drugs against Marburg virus exist, and treatment of the disease is limited to supportive care.

Investigators from the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the National Microbiology Laboratory at the Public Health Agency of Canada (PHAC) created the vaccine against Marburg virus by replacing a gene from a harmless virus--known as vesicular stomatitis virus, or VSV--with a gene encoding a Marburg virus surface protein.

The team infected five rhesus monkeys with the Marburg virus and then injected them with the vaccine (known as recombinant VSV, or rVSV) 20 to 30 minutes later.

Another three monkeys infected with Marburg virus acted as controls and received a vaccine without the Marburg protein.

All of the monkeys treated with rVSV following exposure to the Marburg virus survived for at least 80 days, while the controls succumbed to the disease by day 12.

In a study published in June 2005, the research team reported that the rVSV vaccine could prevent Marburg hemorrhagic fever from developing when administered before infection. The new results suggest that the vaccine could also be an effective post-exposure treatment for the disease.

"These results are very encouraging, as this is the first demonstration of complete post-exposure protection of nonhuman primates against a filovirus," said Thomas W. Geisbert, one of the USAMRIID investigators.

Colonel George W. Korch, Jr., commander of the Institute, added, "This outstanding collaboration has been instrumental in producing novel breakthroughs, such as this, for discovery of medical approaches for difficult public health and biodefense problems."

###

PHAC's National Microbiology Laboratory is Canada's only Containment Level 4 laboratory, where pathogens such as Ebola and Marburg can be worked with safely. The Winnipeg-based laboratory has been at the forefront of research into SARS, West Nile virus, anthrax and other dangerous pathogens.

USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.

April 25, 2006

Missing bioterror substances have officials guessing

By WAYNE PARRYThe Associated Press

NEWARK, N.J. - In the past year, two New Jersey laboratories have been unable to account for plague-infested mice and vials of deadly anthrax spores, and top state officials are scrambling to devise better ways to safeguard deadly material.

In both cases, authorities say they think the items in question weren't actually lost, but were simply unaccounted for due to clerical errors.

They can't say for sure - and that has a Rutgers microbiologist predicting more trouble if such substances aren't kept at a central location.

"The fact that they don't know the answer means they're not running a properly secured facility," professor Richard Ebright said of both cases. "The odds are that it was an accounting error, but it is very possible that one of the persons with access to the lab has removed that material."

Last week, state health officials said they could not account for two vials of anthrax bacteria once thought to have been stored at a government laboratory in Trenton. In September, a Newark health research lab lost track of three mice infected with the bacteria responsible for bubonic plague.

The mice were never located, and officials said the rodents might have been stolen, eaten by other lab animals or just misplaced in a paperwork error.

While the FBI and state authorities are investigating the possibility that the anthrax and mice were removed from the labs, they believe that no crimes have been committed. The state Health Department plans to tell federal authorities on Wednesday it believes the anthrax case is the result of a counting error.

Samples of anthrax has been stored at a Trenton lab since shortly after the October 2001 anthrax mailings that went through a Hamilton, N.J., post office, killing four people across the country and sickened 17.

Richard Canas, New Jersey's Homeland Security director, said it does appear an accounting error is to blame for the latest case. But he wants better safeguards put in place, including disposing of some of the samples.

"I think the genesis was that they were inundated with samples," Canas said. "What I would like to see is bringing this number down. Let's at least cull these down into something more manageable."

Ebright, who has been critical of the nation's bioterrorism safety efforts since the anthrax attacks, said more than 300 institutions nationwide and 16,500 individuals were given government clearance to possess deadly bio-agents such as anthrax as part of a plan to study and protect the specimens.

"After the mailings in 2001, the logical approach was to tightly restrict the number of institutions and officials with access to the materials," he said. "Precisely the opposite has happened, unfortunately. This is a case when we've spent money to put ourselves at greater risk."

That's not to say facilities haven't taken stronger steps on their own. The Trenton lab where the anthrax spores were stored has multiple layers of security, including a padlocked containment area requiring two different sets of identification for access. Only 11 people have such clearance, and all have been questioned, authorities said.

The lab also has video monitoring and 24-hour security guards.

The Newark lab that lost track of the plague-infested mice conducts bioterrorism research for the federal government. After the incident, the facility improved its video surveillance and stopped using contracted animal handlers. Before the incident, the center relied on a single security guard.

Ebright said the U.S. should store all its hazardous bio-agents at a single, secure location rather than having them scattered across the country.

"If an adversary of the United States, such as al-Qaida, wanted to obtain this material, the most effective, simple procedure to do so is to plant a person in one of those numerous institutions that the administration has put in place working with this material," he said. "Because the number of those institutions has increased and because it happened without an increase in effective security, the risk to the United States has dramatically increased."

April 24, 2006

BioSante Pharmaceuticals, Inc. (AMEX:BPA) today announced positive results of a new study demonstrating that its calcium phosphate (CaP) nanoparticle-based vaccine adjuvant, BioVant(TM), may serve as a vaccine adjuvant for the development of an effective vaccine against H5N1 avian flu, widely known as bird flu.

"As the potential danger of a pandemic rises, the need for a safe and effective bird flu vaccine grows increasingly urgent," said Stephen M. Simes, president and chief executive officer of BioSante. "A vaccine with an adjuvant included may allow for better efficacy and lower doses per vaccination which may help to prevent shortages. More importantly, addition of an adjuvant may enable more people to produce an immune response to protect them from disease."

Addition of a vaccine adjuvant has increased in importance due to a paper published in a recent issue of the New England Journal of Medicine. It was reported that an experimental bird-flu vaccine under development by the U.S. government and a European drug company without an adjuvant is effective only at high doses and that only 54 percent of subjects produced the desired immune response.

BioSante's preclinical study's objective was to determine whether BioVant could enhance the body's natural immune response to the H5N1 viral antigen, the cause of bird flu. At the start of the 10-week trial, mice received either the H5N1 antigen alone or in a formulation with BioVant. A booster immunization was administered after two weeks. Results indicated that the administration of a BioVant/H5N1 formulation stimulated production of high titers of H5N1-specific antibodies, and significantly higher than H5N1 alone. Anti-avian flu antibody levels continued to increase over the entire study period, suggesting good duration of immunity.

"These new H5N1 plus BioVant adjuvant study results may represent an important advance toward protecting the human population against a potentially deadly virus," said Dr. Steve Bell, vice president of research and preclinical development at BioSante. He noted that the demonstrated effectiveness of BioVant may also permit a reduction in the needed dosage of H5N1 antigen, which is currently in limited supply. Dr. Bell will present BioSante's avian flu data on May 8, 2006 at the Ninth Annual Conference on Vaccine Research in Baltimore, Maryland.

Avian flu refers to a large group of different influenza viruses that primarily affect birds. While the vast majority of these viruses do not affect humans, the H5N1 strain has already made the jump from birds to humans and in fact, has infected 186 people and killed 108 over the past two to three years. There is widespread concern that a strain of avian flu will mutate into a new form that is contagious among humans. Since there is currently no vaccine available to protect humans from H5N1 and humans do not have antibodies to fight this new virus strain, there is significant risk of a pandemic.

An adjuvant is a substance that, when added to a vaccine, enhances the vaccine's effectiveness by stimulating an immune system response. While aluminum salt derivatives such as alum are the only adjuvants currently approved by the FDA, alum has been associated with adverse reactions such as irritation and inflammation at the injection site, and may exacerbate allergy.

In contrast, BioVant is composed of specially formulated calcium phosphate (CaP), a compound similar to that found in teeth and bones. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown to both prevent the manifestation of allergy, and, to effectively 'switch off' established Th2-T-cell-associated allergic disease.

"We believe CaP, in the form of BioVant, shows potential to be an important non-injection delivery system and adjuvant for the next generation of vaccines against both viral and bacterial infections," Simes said. "In addition to the avian flu vaccine, BioSante and several commercial and military partners are now conducting additional pre-clinical studies of BioVant in several potential vaccines, and the company is pursuing additional collaborations and licenses for further development of CaP."

FDA Is Criticized Over Drugs' Safety Problems

Response to Approved Medications Cited

By Marc KaufmanWashington Post Staff Writer

The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.

The review by the Government Accountability Office found that the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings.

The report also calls on Congress to consider expanding the FDA's authority to require that drug companies conduct studies of already-approved products. The agency's ability to order post-market studies is now limited, and many drug companies have been slow to conduct studies that they had agreed to undertake as a condition of gaining FDA approval.

The GAO inquiry was requested by Congress in 2004 after the sudden withdrawal of the blockbuster painkiller Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users. Several bills that would toughen the FDA's safety oversight were introduced after the Vioxx withdrawal, and the report offers their sponsors new ammunition.

The FDA was widely criticized for moving too slowly in its review of the potential health problems with Vioxx, which was taken by millions, but the GAO report took the criticism a major step forward: It concluded that the agency's entire system for reviewing the safety of drugs already on the market is too limited and broadly flawed.

GAO's examiners studied the agency's handling of four controversial drugs -- the cholesterol-lowering drug Baycol, the painkiller Bextra, the rheumatoid arthritis drug Arava, and the nighttime heartburn medication Propulsid -- and concluded that "there is a lack of criteria for determining what safety actions to take and when to take them."

All but Arava were ultimately taken off the market because of safety concerns, but the GAO found that disputes between two arms of the FDA's Center for Drug Evaluation and Research slowed the process. Since 2000, 10 drugs have been withdrawn by their manufacturers for safety reasons.

The report found that the Office of Drug Safety, which monitors reports of emerging safety risks, at times made recommendations that were ignored by the larger and more influential Office of New Drugs. The GAO also criticized the way experts in the Office of Drug Safety were kept from speaking at important advisory committee meetings on drugs they were studying. The drug safety office has seen considerable turnover, with eight directors in the past 10 years.

"This report provides solid evidence that everything is not all right at the FDA and calls for long-overdue reform," said Sen. Charles E. Grassley (R-Iowa), who requested the GAO report with Rep. Joe Barton (R-Tex.). Grassley and Sen. Christopher J. Dodd (D-Conn.) have introduced a bill that Grassley said would give the post-market review process "real teeth."

Barton said that "the GAO report shows that the drug safety system is not in crisis, but the FDA's process may need some fine-tuning."

In its formal response, the FDA said the report was "well done" and that the "conclusions reached are reasonable and consistent with actions we already have underway or planned."

Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry group "believes that the FDA takes the post-market surveillance of prescription drugs seriously and has taken additional steps over the past couple of years to help ensure that patient safety cannot be compromised." She added that only 3 percent of all approved drugs were later withdrawn.

In the aftermath of the Vioxx withdrawal, the FDA created the Drug Safety Oversight Board, with expanded ability to act on emerging safety issues. The GAO report makes clear, however, that its reviewers consider FDA's actions insufficient. The new board may help provide greater oversight of high-level safety decisions, the report said, but "it does not address the lack of systematic tracking of ongoing safety issues."

To gain approval of a new drug, companies generally conduct clinical trials with hundreds or thousands of volunteers to determine whether the product is safe and effective. But some safety risks may not surface until it has been taken by millions of people.

Since the Vioxx controversy, the FDA has begun posting previously withheld preliminary information about possible drug safety problems and has been quicker to highlight potential risks. But the GAO said the information available to the FDA on potential problems is still limited.

Its system for collecting reports of "adverse events," for instance, is a voluntary one that does not require doctors to report drug-related problems they encounter. Experts estimate that only about 10 percent are reported.

Alastair Wood of Vanderbilt University, a prominent voice on the FDA's advisory panel on drug safety and risk management, said the GAO report "confirmed a lot of what people have been saying for some time."

Wood said the FDA is still refusing to take the bold steps he believes are necessary to ensure drug safety. "Frankly, it doesn't look right now as if much has changed," he said.

April 20, 2006

Doomsday predictions about bird flu seem to be spreading faster than the virus itself. But a small group of skeptics say the bird flu hype is overblown and ultimately harmful to the public's health.

There's no guarantee bird flu will become a pandemic, and if it does there's no guarantee it will kill millions of people. The real trouble, these skeptics say, is that bird flu hysteria is sapping money and attention away from more important health threats. "I have a bunch of patients coming in here who are more worried about bird flu than they are about heart disease," said Dr. Marc Siegel, an internist and associate professor of medicine at the New York University School of Medicine. "The fear is out of proportion to the current risk."

Even Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief, recently cautioned against overreacting if the virus surfaces in North American birds, as it is expected to do later this year.

"One migratory bird does not a pandemic make," Fauci told The Associated Press.

Scary scenarios

It's hard to blame people for feeling skittish. The chief avian flu coordinator for the United Nations, Dave Nabarro, said last fall he was "almost certain" a bird flu pandemic would strike soon, and predicted up to 150 million deaths. The U.S. Secretary of Health and Human Services, Mike Leavitt, advised Americans to stockpile cans of tuna fish and powdered milk under their beds in case of an outbreak. Renowned flu expert Robert Webster has said society needs to face the possibility that half of the population could die in a bird flu pandemic.

"Ridiculous," scoffed Wendy Orent, an anthropologist and author of "Plague: The Mysterious Past and Terrifying Future of the World's Most Dangerous Disease."She said public health officials have vastly exaggerated the potential danger of bird flu. Several factors make it unlikely that bird flu will become a dangerous pandemic, Orent said: the virus, H5N1, is still several mutations away from being able to spread easily between people; and the virus generally attaches to the deepest part of the lungs, making it harder to transmit by coughing or breathing.

"We don't have anything that makes us think this bug will go pandemic," Orent said. "Yes, it's virtually certain in human history there will be another pandemic strain . but there's no reason for it to happen now, or 10 years from now or 20 years from now."

Public health officials counter that it's better to be safe than sorry; better to prepare for a pandemic that never comes than to be caught unprepared. Avian flu has killed 110 people worldwide since 2003, according to the World Health Organization.

"Even if H5N1 does not evolve into a pandemic, the steps we are taking right now will benefit us down the road," said Tom Skinner, a spokesman for the Centers for Disease Control and Prevention in Atlanta. "We simply want people to be informed and educated about bird flu. The best antidote for fear is information."

But public health funding is a zero-sum game, both Orent and Siegel note. Money that's being poured into short-term bird flu preparations isn't available for long-term fixes that would, for example, increase hospitals' ability to handle a surge of patients in a national emergency.

"People have been riding this for all they can get," said Orent. "We don't need to make this into something it's not in order to get what we need, which is a better public health system."

All the eggs in one basket?

And while everyone is nervously watching bird flu progress through Asia and Europe, some experts worry another bug could sneak up and bite us.

"Preparation is fine, but short-term hysteria interferes with long-term planning," Siegel said. He said he'd like to see more efforts at general pandemic preparation - such as developing better methods for making vaccines - rather than a laser-like focus on H5N1. "We're putting all our eggs in one basket."

Flu virologist Adolfo Garcia-Sastre, a microbiology professor at the Mount Sinai School of Medicine in New York, agrees that all the focus on H5N1 may be unhealthy. As part of the team of scientists who recreated the deadly 1918 flu strain, he's glad people are paying more attention to flu but thinks the level of worry is a bit too high. If this avian flu doesn't turn into a pandemic, he wonders, will all these new flu-fighting measures be tossed aside?

"Focusing only on H5N1 ... I think is a little bit shortsighted," Garcia-Sastre said.Public health officials always have to walk a fine line when sounding the alarm, said risk communications expert Peter Sandman, of Princeton, N.J., a consultant to the World Health Organization and the U.S. Department of Defense. Bird flu is a tough case because it's both scary and unlikely. People see-saw between overreacting because the potential threat is horrific, and under-reacting because the threat is also unlikely.

"When you look at a risk that's horrific but not likely, it's hard to know how to think about it," Sandman said.

Sandman said public health officials need to do a better job of communicating the uncertainty around bird flu - as Fauci seemed to be attempting this week.

"It's unfair and dishonest to make it sound like we're sure H5N1 is coming soon and it's going to kill half the population," Sandman said. "It's equally irresponsible to say, because only a hundred people have died, it's not a biggie. It's potentially very scary, but potentially is only potentially."

Mixed messages

Vocabulary is part of the problem, Sandman said. The term "bird flu" is used for the virus that is now killing birds - and has infected nearly 200 people who came into very close contact with birds. And it's also being used to describe a mutated virus - which hasn't yet emerged - that would spread easily among humans.

Sandman stressed that the current "bird flu" that kills birds is not the same as the potential "bird flu" that could cause a deadly pandemic.

"Chicken isn't a problem," he explained. "The big problem is the risk of mutation, at which point I'm at risk from the subway seat you sat on, or the doorknob you pulled open. After the mutation happens we should both be more afraid of doorknobs than chicken. Before the mutation, we shouldn't be afraid of doorknobs or chickens."

Even if avian flu transforms into a human pandemic, it may be mild. The most recent flu pandemic, in 1968, went unnoticed by everyone except scientists because it wasn't much worse than a normal flu season in terms of illnesses and deaths.

Government officials continue urging people to prepare by stockpiling a few weeks' worth of food, water and medical supplies. But skeptics like Siegel and Orent say you're better off guarding against more realistic dangers - heart attacks, for example, or even gum disease.

"I'd worry more about flossing my teeth than I'd worry about avian flu," Orent said. "I want people to see what the real dangers are."

Experts Say Bioterror Attack in Australia Unlikely

Global Security Newswire

Security experts said today they did not expect Australia to face a bioterror attack, but added that prevention requires an understanding of the thinking of those who might attempt such a strike, the Australian Associated Press reported (see GSN, March 28).

The experts gathered at the Infectious Diseases and International Security Symposium in Sydney. Among topics discussed were biological weapons, their possible use by terrorists and avian flu, according to AAP.

Experts at the symposium agreed there was only a small chance of a biological attack against Australia.

“It still remains easier to make bangs than bugs,” said Sydney University professor John Hearn.

Australian Defense Force Academy global security expert Christian Enemark said that the threat of a biological attack was overstated following the Sept. 11, 2001, terrorist attacks.

“From a government point of view, yes, you enunciate the worst-case scenario,” he said. “They feel as if they need to have covered the spread of possibilities.”

There have been only three historical cases of nonstate actors using biological weapons, according to AAP. Al-Qaeda was not involved in any of them.

Australian Federal Police official James Robertson said the greatest concern in connection with a public health threat was panic.

“It seems to me that in this area our worst enemy is fear and it's fear of the unknown,” he said.

He added that the public, security and health agencies must share “accurate, nonsensationalist information” on biological threats (Amy Coopes, Australian Associated Press, April 20).

Kansas Law Creates New Terror Crimes

Global Security Newswire

Kansas has instituted a law that creates three new terrorism-related crimes, Infozine.com reported yesterday (see GSN, Sept. 19).

Two of the crimes — terrorism and illegal use of weapons of mass destruction, both carrying a maximum penalty of life imprisonment, have no statute of limitation. They are subject to the state’s electronic surveillance law, according to Infozine.com.

Furthering the commission of the crimes of terrorism or illegal use of weapons of mass destruction carries a penalty between 147 months to 653 months.

“First and foremost we hope we never have to deal with acts of terrorism in our state,” said Governor Kathleen Sebelius. “However, these steps ensure we have the ability to appropriately deal with anyone who commits these heinous actions” (Infozine.com, April 19).

April 19, 2006

Report Finds Anthrax Contamination at U.S. Institute

Global Security Newswire

A new report has indicated that there were multiple incidents of anthrax contamination outside biocontainment areas in 2001 and 2002 at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick in Maryland, the Associated Press reported today (see GSN, Oct. 14, 2004).

The report exposed careless practices by workers at the site as they dealt with an influx of samples submitted for testing. The contamination did not cause any infections, AP reported.

The Army tightened security at the facility after acknowledging an accidental release in April 2002. No additional leaks have been reported since.

The report, first obtained by The Frederick News-Post, states that anthrax spores appear to have contaminated areas months before the April 2002 incident. This occurred while the facility was processing tens of thousands of items and environmental samples, including letters carrying anthrax that were sent to two U.S. senators.

One employee in December 2001 told institute microbiologist Bruce Ivins that she might have been exposed to anthrax while handling a letter. Ivins found what appeared to be traces of the agent on her desk, and decontaminated the area without alerting his superiors.

Ivins told investigators that he treated the area because he was concerned that the substance might not be contained.

Two researchers in April 2002 reported to Ivins that anthrax had leaked from two flasks. Ivins reported this incident to higher-ups, who then discovered anthrax on nasal swabs of one of the workers. This person had been vaccinated against the agent and did not become ill.

Ivins conducted additional unauthorized sampling of noncontainment areas on April 15, AP reported. He discovered spores in his office area, in a pass box and in a changing room. All three tested positive for a disease-causing form of the pathogen, and the changing room was found to be contaminated with two pathogenic forms.

The amounts detected were not enough to endanger the public or workers at the site, according to C.J. Peters, biodefense director at the University of Texas Medical Branch Center for Biodefense and Emerging Infectious Diseases. Peters was deputy commander at the Army institute until 2000.

According to the report, there were probably several instances of anthrax contamination. It found that the likely cause of the leak was the use of old, ineffective bleach in cleansing the pass box, which is used to move materials from laboratories through noncontainment areas.

The report also found that the pass box contamination might have occurred after a letter from the 2001 anthrax attacks was opened. It might have contaminated plastic bags used to transport material.

Institute Commander Col. George Korch Jr., who served as deputy commander in 2002, said no disciplinary action has been taken against individuals named in the report.

“One thing you really want to avoid is, if you find a safety violation, you want to make sure there is an openness and acceptance about not being too punitive. You want to make people feel that they are openly contributing in a way that is not going to shut down (their) inclination to say ‘Hey, this happened,’” Korch said (Associated Press/WTOP, April 19).

Firm Finishes Smallpox Vaccine License Application

Global Security Newswire

British drug maker Acambis PLC said it has completed its application for a U.S. license to market its smallpox vaccine, AFX reported today (see GSN, Jan. 4).The company in January began submitting the application on a rolling basis to the Food and Drug Administration. It includes information from clinical trials on the drug’s safety, tolerability and effectiveness.

The agency in 2004 gave the drug “fast-track” status, AFX reported. Company CEO Gordon Cameron said he expects the FDA review of the drug to be finished this year.Acambis is making the vaccine for the United States and other countries. It is also working on an attenuated smallpox vaccine (AFX/Forbes.com, April 18).

Mississippi National Guard Plans WMD Drill

Global Security Newswire

Members of the Mississippi National Guard tomorrow are scheduled to conduct a drill involving the suspected release of a lethal agent, the Associated Press reported see GSN, June 27, 2005).After an unidentified biological agent or chemical is detected in Canton, Quick Reactionary Force teams are to land by helicopter and secure the area around the city’s Multipurpose Complex. The 47th Civil Support Team, which was formed last year to deal with WMD incidents, will hunt for the agent.

Another 70 soldiers are expected to provide additional support.

The exercise is scheduled to last around three hours, ending when no indications are found of a dangerous substance, AP reported (Associated Press, April 18).

Meanwhile, emergency and school officials in Gwinnett County, Ga., yesterday conducted a sarin attack exercise at a mock high school, the Atlanta Journal-Constitution reported.

The exercise was a simulation of a gas attack on a school of 2,000 students. Sarin was released at the entrance to “Suwanee High School” — in actuality a schools training center — killing a faculty member and injuring a number of students.

The drill involved county police and fire personnel, school officials, and officials from the cities of Duluth and Suwanee, the Journal-Constitution reported.

April 18, 2006

Firm Finishes Smallpox Vaccine License Application

Global Security Newswire

British drug maker Acambis PLC said it has completed its application for a U.S. license to market its smallpox vaccine, AFX reported today (see GSN, Jan. 4).The company in January began submitting the application on a rolling basis to the Food and Drug Administration. It includes information from clinical trials on the drug’s safety, tolerability and effectiveness.

The agency in 2004 gave the drug “fast-track” status, AFX reported. Company CEO Gordon Cameron said he expects the FDA review of the drug to be finished this year.Acambis is making the vaccine for the United States and other countries. It is also working on an attenuated smallpox vaccine (AFX/Forbes.com, April 18).

Mississippi National Guard Plans WMD Drill

Global Security Newswire

Members of the Mississippi National Guard tomorrow are scheduled to conduct a drill involving the suspected release of a lethal agent, the Associated Press reported (see GSN, June 27, 2005).After an unidentified biological agent or chemical is detected in Canton, Quick Reactionary Force teams are to land by helicopter and secure the area around the city’s Multipurpose Complex. The 47th Civil Support Team, which was formed last year to deal with WMD incidents, will hunt for the agent.

Another 70 soldiers are expected to provide additional support.

The exercise is scheduled to last around three hours, ending when no indications are found of a dangerous substance, AP reported (Associated Press, April 18).

Meanwhile, emergency and school officials in Gwinnett County, Ga., yesterday conducted a sarin attack exercise at a mock high school, the Atlanta Journal-Constitution reported.

The exercise was a simulation of a gas attack on a school of 2,000 students. Sarin was released at the entrance to “Suwanee High School” — in actuality a schools training center — killing a faculty member and injuring a number of students.

The drill involved county police and fire personnel, school officials, and officials from the cities of Duluth and Suwanee, the Journal-Constitution reported.

ABC PLANS 'BIRD FLU' THRILLER FOR MAY SWEEPS

You may not want to order in hot wings for your couch viewing next month: ABC has announced a May Sweeps' bird-flu thriller!

"Fatal Contact: Bird Flu in America" is set to air May 9, reports Michael Starr at the NY POST.

The movie stars Stacy Keach, Joely Richardson, Ann Cusack and Justine Machado in a tale of a worst-case scenario, if the bird-flu virus was transmitted to humans in America.

"We feel we're providing a level of awareness and we've gone to great effort to make sure the film is accurate," co-producer Judith Verno said. "We've included a lot of information we believe people need to know."

"We had wonderful consultants who were actually ahead of the [bird-flu] curve," Kerew said. "The way the disease popped up in China, then moved to Turkey and Africa, were things we already knew about."

"Our movie has a character who was in Iraq and got the bird flu there and survived - and, as we were shooting, the bird flu hit Iraq," Verno said.

"There is no evidence it will be the next pandemic," Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention in Atlanta, said of avian flu. There is "no evidence it is evolving in a direction that is becoming more transmissible to people."

April 17, 2006

NIH Looking to Use MF59 (squallene) in Regular Flu Vaccines

Put aside hypothetical worries about bird flu: Regular flu already kills elderly Americans in droves every winter because the vaccine simply doesn't work as well inside aging bodies as young ones.

The National Institutes of Health wants to strengthen flu shots destined for the elderly, part of a push to get the nation to start treating influenza's yearly attack as seriously as the threat of some super-flu striking in the future.

The message: Why wait for a pandemic to benefit from better flu vaccines and treatments?

"My great frustration (is) in trying to shake the cage and say, 'We have not, by any means, optimized how we approach seasonal flu,'" Dr. Anthony Fauci, the NIH's infectious disease chief, told The Associated Press.

Topping his do-better list: testing whether higher vaccine doses or adding immune-boosting compounds to the shots some of the same compounds already being studied to fight bird flu would improve the elderly's protection against regular winter influenza.

In Europe, U.S. flu-shot supplier Chiron Corp. already sells a revved-up version just for people over age 65. Studies mostly from Italy suggest that adding a chemical called MF59 to Chiron's regular flu shot spurs a modestly better immune response in older people, especially the frail.

Chiron wouldn't say if it plans to eventually bring that shot, called Fluad, to the United States; it sells about 20 million doses abroad. Instead, Chiron's U.S. focus has been on testing whether MF59 could improve experimental vaccines against bird flu.

But Fluad is among the approaches catching Fauci's interest as he plans new research into improved elder vaccines.

Also, at least one well-known vaccine research center, at St. Louis University School of Medicine, is planning a study of higher flu vaccine doses for the elderly this fall.

And NIH recently began recruiting 150 U.S. volunteers to study just which parts of the immune system change as we age to make flu a more serious threat, basic biological underpinnings that remain a mystery despite influenza's unrelenting yearly toll.

Here's the sad irony: Influenza kills 36,000 Americans in an average winter, many more during harsh flu seasons and people over age 65 make up 90 percent of those deaths. Yet flu vaccine is less effective in the people who need it most, protecting roughly 60 percent of elderly recipients compared with 75 percent to 90 percent of young healthy people.

Just as the body's physical abilities typically slow with age, the immune system can become sluggish. It's not impossible to rev it back up. Some earlier research suggests that giving four to six times the normal dose of a flu vaccine component could double the elderly's immune response, says Dr. John Treanor, a University of Rochester vaccine specialist.

The question is whether pumped-up vaccines for the elderly would provide enough extra protection to be worth it. Some previous attempts have found only slight improvements, and souped-up vaccines cost more to make.

"Until recently there was a lot of reluctance to do anything that would make the vaccine more expensive," Treanor says, speculating that cost might be a key reason that Chiron debuted its Fluad shot in Europe.

A stronger vaccine might also come with more side effects, cautions Dr. Donald J. Kennedy of St. Louis University.

Still, there are low-risk strategies to test. Aside from the simple higher-dose study his university colleagues are planning, Kennedy wonders if giving seniors a flu shot plus a second vaccine the FluMist nasal spray made of live but weakened flu virus might activate different immune pathways to improve protection.

Ultimately, what may protect the elderly the most is when flu's main spreaders healthy young people, especially schoolchildren start getting vaccinated in high-enough numbers to stem the virus' tide.

For the first time this fall, all children from age six months to 5 years will be recommended for a flu shot. Until now, the government pushed childhood flu vaccine just for chronically ill youngsters and healthy tots up to age 2.

Expect even more children to be on the vaccine list as early as 2007; already under discussion is the 5- to 9-year-old crowd.

And with a record 120 million vaccine doses expected this year far more than the most ever given, 83 million doses the government is preparing to encourage inoculations for healthy 20-, 30- and 40-somethings this fall, too.

April 16, 2006

U.S. Readies Emergency Bird Flu Plan

Associated PressBy NEDRA PICKLER

In the event of a bird flu outbreak, U.S. money could be produced overseas and Americans checked in drive-through medical exams for signs of infection, according to government plans being finalized.Federal officials say the first case of bird flu could show up in the United States in the coming weeks or months as birds migrate from overseas. President Bush is expected to approve a national response plan in the next week or two laying out how agencies should respond if it were transmitted to humans.

The plan assumes a worst-case scenario that as many as 90 million people in the U.S. would become sick and 2 million would die during a worldwide flu pandemic.

It envisions people may need to avoid human contact and stay home from work, school and other large gathering places, according to officials familiar with draft. Some details of the draft, first in Sunday's Washington Post, were confirmed by officials at the White House who spoke anonymously because the plan has not been finalized.

Dr. Bruce Gellin, director of the National Vaccine Program Office at the Health and Human Services Department, said the report builds on the strategy that Bush outlined six months ago - new flu-vaccine technology and greater stockpiles of vaccines and antivirals.

The government had focused on health issues in that earlier report, but a pandemic would affect every aspect of government, Gellin said.

The response plan, assembled by the president's Homeland Security Council, lays out who should be the first vaccinated, proposes that other countries make U.S. money if domestic locations cannot operate. The plan anticipates that employees could strain Internet capacity while working from home computers.

The U.S. has had such money agreements with allies in the past in case of emergency, a White House official said, but there is no current arrangement. Congress approval would be needed for a new deal.

The Veterans Affairs Department has developed a medical exam that could be conducted in VA hospital parking lots, with those who suspect they may be infected able to get a quick exam. The program is modeled after a drive-through flu vaccination program conducted last year.

Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief, said in an interview with The Associated Press last week that scientists are debating whether to vaccinate first those most likely to spread the virus, rather than those traditionally first in line for winter flu shots, including the very old, very young and chronically ill. That policy still is under debate, he said.

Bird flu threat not so grave, CDC chief says

"There is no evidence it will be the next pandemic," Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention in Atlanta, said of avian flu. There is "no evidence it is evolving in a direction that is becoming more transmissible to people."

Gerberding spoke at the Greater Tacoma Convention & Trade Center at a pandemic flu conference that drew 1,200 people from across the state, mostly health department officials and others involved in emergency planning.

Other officials from the U.S. Department of Health and Human Services, the U.S. Department of Agriculture and elsewhere joined her. Gov. Chris Gregoire and several upper-level state officials also spoke.

Gerberding's comments on bird flu contrast earlier statements from the federal government that tended to emphasize worse-case scenarios.

In a November letter to the public, for instance, President Bush encouraged preparing "ourselves, our nation, and our world to fight this potentially devastating outbreak of infectious disease."

The concern is that the H5N1 strain of bird flu virus will mutate into a form passed easily between people.

But Gerberding noted that, though the disease has killed "gazillions of birds," it has killed about 100 people out of about 200 sickened worldwide. The victims were in intense, daily contact with sick flocks, often sharing the same living space. Two people have become infected from person-to-person contact.

She did not say what had changed the thinking of health care officials about bird flu, but said that, at this point, there is "no reason to think it ever will" pass easily between people.

Given those facts, bird flu, like SARS, swine flu and other once widely publicized health threats, might never become a significant human illness.

The visit by Gerberding and the other federal officials was part of a 50-state tour to encourage state and local planning for pandemics, terrorism and other health emergencies.

Such preparedness would be especially important, since local officials would be the first to learn of problems, and a full federal response couldn't be expected for a few days.

It was announced at the meeting that Washington state has been granted $2 million

. federal money to help with planning.

Several officials said state and local planning in Washington already is among the best in the nation.

"We have an effective state strategy," Gregoire said, noting the need for constant fine-tuning and updating. "Today we talk about pandemic flu. In 10 years it will be something else" - the important thing is to be ready for whatever comes.

easy precautions to take

Even if bird flu never causes significant problems for people, Gerberding said, the focus on it encourages emergency planning "that will save lives whether there is a pandemic or not."

She and other federal officials said H5N1 bird flu likely will reach the United States, because bird flu and its many strains occur naturally in migratory birds.

When that happens, "it does not signal the start of a pandemic" or a threat to the food supply, said Richard Raymond, an undersecretary at the U.S. Department of Agriculture.

Cooking meat to 160 degrees will destroy the virus, he said - in addition to destroying salmonella, "which sickens more people than H5N1 ever will even if there is a pandemic."

Gerberding cautioned that when H5N1 is detected in the United States, "there will be temptation for the press to make this into something it is not. We will need responsible journalism" to prevent irrational panic. M. Alexander Otto: 253-597-8616, alex.otto@thenewstribune.com

New anthrax vaccine has same makeup, more consistent doses

By Faith BremnerCapital News Service

WASHINGTON - On the recommendation of the Institute of Medicine, the U.S. Department of Health and Human Services decided to seek a new type of anthrax vaccine, called a recombinant anthrax vaccine, for the nation's stockpile. This new vaccine is supposed to provide a more consistent dose of antibody-producing antigen than the current vaccine does.

VaxGen of Brisbane, Calif., is developing the new vaccine. BioPort Corp. has been producing the older version at its Lansing plant since 1970.

What's the difference between the vaccines?

Both vaccines work the same way. They consist of proteins from the anthrax bacteria, which cause the immune system to respond and make antibodies, and adjuvant, a chemical compound that stimulates the immune system.

Their differences lie in how they're manufactured. Through genetic engineering, the newer vaccine's anthrax proteins are highly purified and selected for their effectiveness, which gives the manufacturer consistency from one batch to the next. The anthrax proteins in the older vaccine are more variable, which leads to small inconsistencies in each batch.

Is one vaccine type more effective than the other?

In theory, they eventually should be equally effective at protecting humans against anthrax.

A 2002 Institute of Medicine study found that BioPort's vaccine is effective and safe.

VaxGen is still conducting clinical trials to determine whether its product is as effective as BioPort's.

The VaxGen vaccine has run into a problem that often happens with recombinant vaccines - its proteins are so pure that they fail to cause enough inflammation within the body to induce a high immune system response.

Why isn't BioPort manufacturing the new vaccine?

The company declined to bid on the contract because it did not want to pursue a technology that company officials say is not significantly better than the one they already use. Instead, they would like to develop vaccines that could be administered via a patch or a pill and that could be stored at room temperature.

April 15, 2006

Contract delay hurts Lansing vaccine firm

Lansing State JournalBY FAITH BREMNER

WASHINGTON -- A Lansing-based vaccine manufacturer could be out of business soon if the federal government fails to follow through with a commitment to buy 5 million doses of its anthrax vaccine, U.S. Rep. Mike Rogers said last week.

For a year, Rogers said, officials at the Department of Health and Human Services have been telling him a contract with BioPort Corp. is imminent. As of Friday, no contract had been signed.

Last year, the department bought 5 million doses of the vaccine at a cost of $122 million for the nation's stockpile of medicines, called Project BioShield, that would be used to protect Americans from a terrorist attack.

The 10 million doses are supposed to act as a bridge until a new type of anthrax vaccine is developed by a competitor, VaxGen of Brisbane, Calif. That company has an $877.5-million contract with HHS to deliver 75 million doses of its vaccine to the stockpile starting this year. VaxGen is six months to a year behind schedule and having problems getting its vaccine to work properly.

Rogers is concerned that BioPort, the nation's only anthrax vaccine manufacturer licensed by the Food and Drug Administration, might be forced to close if the contract doesn't come through soon. The company employs 325 people at its Lansing plant and another 125 at a research facility in Maryland.

BioPort President and Chief Executive Officer Robert Kramer declined to say whether his company is considering laying off employees. In October, the firm let 38 workers go. BioPort is also developing vaccines for botulism and typhoid fever.

"If (BioPort) goes away, that's it. We have no FDA-approved company in the U.S.," Rogers said.

"We are right now very much dependent upon a commitment by the federal government, both the Department of Defense and Health and Human Services, for procurement of the product," Kramer said.

Both BioPort and VaxGen have had financial and production problems before.

It took BioPort three years to get an FDA license after it bought its Lansing plant from the State of Michigan in 1998 and renovated it. The military invested $125 million in the plant to help get it running.

VaxGen was delisted by Nasdaq in 2004 and is redoing some of its annual financial statements.

Rogers is calling on the House Energy and Commerce Committee, which has jurisdiction over the BioShield stockpile, to investigate the way HHS is handling the anthrax vaccine contracts.

April 14, 2006

12 Volunteers to Start Getting HIV Vaccine

By MIKE STOBBEThe Associated Press

ATLANTA -- Human volunteers this week began signing up for an experimental HIV vaccine developed at Atlanta's Emory University.

Twelve people are expected to take part in the trial at four participating research centers _ St. Louis University, Vanderbilt University, the University of Maryland and the University of Alabama at Birmingham.

Volunteers should begin getting shots any day now, said Don Hildebrand, the chief executive of GeoVax Inc., the Atlanta biotechnology firm that licensed the vaccine.

It's a phase one trial, in which healthy, uninfected volunteers are given low doses in a check for safety and immune response, Hildebrand said Friday.

A second, higher-dose trial with 36 people is expected to begin in a few months.

If these trials are successful, future trials will be done to see if the vaccine actually prevents the virus from causing AIDS, he said.

The GeoVax product is one of more than 30 preventive AIDS vaccines in early stages of human clinical trials in approximately two dozen countries, according to the International AIDS Vaccine Initiative, a not-for-profit organization devoted to AIDS prevention.

One of the furthest along is a Merck & Co. vaccine, which tries to build immunity using a modified cold virus. About 3,000 people are being enrolled in Merck's phase two trial of the vaccine.

The GeoVax vaccine is administered in four doses, spread over the course of about two months. The first two doses contain fragments of HIV DNA, which prime the patient's immune response system. The second two doses contain an altered poxvirus designed to boost the immune system, Hildebrand said.

It was developed by a scientific team led by Harriet Robinson of Emory's Yerkes National Primate Research Center. Emory researchers began working on the vaccine in 1997. It worked in rhesus macaques, protecting 22 of 23 vaccinated monkeys from AIDS for more than 3 1/2 years.

In 2003 and 2004, the DNA component of the vaccine was tested in 30 HIV-negative volunteers in Birmingham, Seattle and San Francisco. It was deemed safe, Hildebrand said. The new trials are testing both the components, he explained.

April 12, 2006

Two trailers proclaimed by the Bush administration for months after the invasion of Iraq to be mobile biological weapons laboratories were believed even at the time by U.S. intelligence to have nothing to do with biological weapons, the Washington Post reported today (see GSN, Nov. 29, 2005).

On May 29, 2003, Bush said, "We have found the weapons of mass destruction."

However, U.S. intelligence officials had already received evidence to the contrary, according to the Post. Leaders of a secret Pentagon-sponsored fact-finding mission had concluded that the trailers were not involved with biological weapons and transmitted their findings in a report on May 27, 2003.

The report and a longer follow-up issued three weeks later were stamped "secret" and shelved. White House and intelligence officials continued for nearly a year afterward to argue that the trailers were involved in biological weapons production.

"There was no connection to anything biological," said one expert who examined the trailers.

"Within the first four hours it was clear to everyone that these were not biological labs," said another team member.

A Defense Intelligence Agency spokesman said the findings were not covered up, but rather included in the work of the Iraqi Survey Group, which said in a final September 2004 report that the trailers were "impractical" for weapons production and were "almost certainly intended" as hydrogen-manufacturing laboratories for weather balloons.

Intelligence analysts said the initial team was one of several that analyzed the trailers in the months after the March 2003 invasion. They said two teams of military experts believed they were intended to produce weapons.

"It was hotly debated, and there were experts making arguments on both sides," said one former senior official.

On May 28, 2003, the CIA said in its first formal assessment of the trailers that U.S. officials were "confident" they were involved in "mobile biological weapons production." Then-Secretary of State Colin Powell in June declared that the "confidence level is increasing" on that assessment. In September, Vice President Dick Cheney called the trailers "mobile biological facilities" possibly used to produce anthrax or smallpox, the Post reported.

Some team members complained that their report was never publicly acknowledged.

"I went home and fully expected that our findings would be publicly stated," one member said. "It never happened. And I just had to live with it" (Joby Warrick, Washington Post, April 12).

April 11, 2006

Critics Decry Spending on Anthrax Vaccine

Global Security Newswire

Critics of the more than $1 billion in federal spending to develop and stockpile anthrax vaccines said the United States would be better off preparing for a biological attack that could involve other agents, the Hartford Courant reported yesterday (see GSN, April 7).

These critics have argued that terrorist have not shown any capability to execute a large-scale anthrax attack and that antibiotics could be used to treat victims of such in incident. They have said politics is driving the spending on anthrax.

Officials are concerned that terrorists could disperse anthrax spores in aerosol form over an urban center, putting the population at risk for inhalation anthrax. There are a half-dozen agents that deserve particular preparedness attention, including anthrax and smallpox, said David Ropeik, risk communication director at Harvard University's Center for Risk Analysis.

There was $418 million in biodefense spending in fiscal 2001. This rose to $3.7 billion in 2002, in the wake of the Sept. 11 attacks and subsequent anthrax mailings, and has increased annually since.

The 2004 Project Bioshield legislation authorized spending of $5.6 billion in 10 years for bioterrorism countermeasures. Of this amount, $1.4 million is designated for anthrax vaccines.

The military for years has considered anthrax the greatest biological threat.

"The chairman of the Joint Chiefs of Staff considers anthrax to be the No. 1 biological threat agent," said Defense Department spokeswoman Barbara Goodno. "Other government agencies and civilian authorities agree. The lethal anthrax attacks of fall 2001, including a death in Connecticut, show how easy it is to disperse anthrax spores with deadly effect."

Some weapons experts have said the anthrax threat has been overstated and that there is no evidence that terrorist groups have been able to develop viable anthrax spores.

Anthrax spores can be delivered through the air and remain virulent longer than other agents. However, scientists have said that it would be as easy to distribute pathogens such as ricin and botulinum.

They have also said that anthrax is difficult to make and use and that winds can affect how the agent is spread.

The government needs to decide which agents to target and which are being promoted for "a political reason," said Victor Sidel, co-author of "Terrorism and Public Health: A Balanced Approach to Strengthening Systems and Protecting People."

Retired Air Force Col. John Richardson agreed.

"Politicians only want to be able to say - in the aftermath of a terrorist event -that, 'We did all we could do,'" he said. "Defending against hypothetical bioterrorism deaths will bring in votes and contributions. The spending is driven by political expediency, not the threat."

Money would be better spent on after-attack treatment, said Barbara Loe Fisher, president of the National Vaccine Information Center.

"Despite the fear and hysteria that has been created by physician health officials inside and outside of the Pentagon, there has not been one shred of evidence presented to the American people that biological weapons, including viable weaponized anthrax supplies, exist and are ready to be unleashed on the U.S.," she said.

Anthrax can be treated following an attack with antibiotics. The Health and Human Services Department said that response to an attack would be treatment with an existing vaccine along with antibiotics. There are enough antibiotics to treat 40 million people, according to the department.

The Food and Drug Administration said last year that these treatment methods are safe and effective, but added "long-term use of such therapies in individuals at high risk for anthrax disease, potentially for a period of years, has not been studied" (Thomas Williams, Hartford Courant, April 10).

April 10, 2006

A Spending Priority

Two of the first three BioShield contracts were awarded to manufacturers of anthrax vaccines: VaxGen Inc. of Brisbane, Calif., was awarded $877.5 million for 75 million doses of a vaccine still under study.

BioPort Corp. of Lansing, Mich., was awarded $122.7 million for manufacture and delivery of 5 million doses of Anthrax Vaccine Adsorbed, a licensed vaccine. A spokesman for the U.S. Department of Health and Human Services said negotiations are underway for the purchase of additional vaccine from BioPort.

The BioShield spending is not the only money paying for development of anthrax vaccines.

In 2003, Avecia of Manchester, England, was awarded a $71.3 million contract for clinical trials of an anthrax vaccine, yet to be licensed, and production of 3 million doses. The award was granted by the National Institute of Allergy and Infectious Diseases.

Last fall, LigoCyte Pharmaceuticals Inc. of Bozeman, Mont., was awarded a $4.6 million challenge grant for an intranasal vaccine against anthrax. The award came from the National Institutes of Health.

At Odds Over Anthrax

The Federal Government Wants To Stockpile Anthrax Vaccines To Protect Americans From A Biological Attack; Critics Question Costs, Wonder If Effort Is Even Necessary

Weaponized anthrax killed five Americans in 2001, yet the federal government is coming under criticism for its pursuit of vaccines to protect the United States from future attacks.

The government has committed to investing more than $1 billion to develop, buy and stockpile anthrax vaccines - fully one-quarter of a special fund created by President Bush for medical countermeasures against chemical, biological, radiological or nuclear attack on the United States.

Some critics, however, insist that the investment is misguided at best. There is no evidence that foreign terrorists are capable of a large-scale anthrax assault, they say, and there are other biological agents terrorists might find as easy to use. In any case, anthrax disease can be treated successfully with antibiotics. Some suggest the spending has more to do with politics than with actual threats.

Concerns over the military's use of the only currently licensed vaccine led to a halt, at least temporarily, to mandatory inoculations there. And although new vaccines are being commissioned, some people have warned that the government needs to better supervise its entire anthrax program or risk wasting money, making flawed decisions, and possibly putting the public in danger.

The issue is far from academic. In the event of a national emergency, the government has the power to order vaccination of civilians, regardless of whether the medications are licensed or experimental.

BioShield Target: Anthrax

It has been more than four years since Ottilie Lundgren took ill at her home in Oxford, Conn., and later died, the last victim of the nation's 2001 anthrax attacks -the only successful attacks of their kind in this country or any other. The FBI's main theory is that the weaponized anthrax was generated by a domestic, not foreign, source and most likely originated in a military laboratory.

The attacks have so far led to no criminal charges. What they did lead to, and quickly, was a realization that the country was ill prepared to defend itself against just such a nonconventional attack.

Anthrax spores used in 2001 were delivered through the mail, but government officials are worried about the potential for even greater harm if aerosolized spores could be released by a sprayer or some other device over an urban center. That scenario could put the population at risk of inhalation anthrax, the kind that killed Lundgren and the four other victims.

The United States has a vital need for a vaccine to protect the public against all forms of anthrax, said David P. Ropeik, director of risk communication at Harvard University's Center for Risk Analysis. Addressing all of the more than two dozen other biological threats would be daunting for taxpayers, he said, but anthrax and smallpox are two of a half-dozen mandating close government attention.

Annual civilian biodefense spending, $418 million in fiscal 2001, soared to $3.7 billion the following year and appreciably more every year since.

In 2004, Bush signed Project BioShield legislation, which authorizes spending $5.6 billion over 10 years to buy and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror against the civilian population.

Of that, $1.4 billion is earmarked to buy and stockpile anthrax vaccines for use in case of a national emergency.

The U.S. Department of Health and Human Services has already begun awarding contracts to buy doses of the only licensed vaccine, Anthrax Vaccine Adsorbed, called AVA, and to develop and stockpile a next-generation vaccine.

For years, inhalation anthrax has been considered by the military to be the foremost threat in biological warfare.

"The chairman of the [Pentagon's] Joint Chiefs of Staff considers anthrax to be the No. 1 biological threat agent," said Barbara Goodno, a Pentagon spokeswoman. "Other government agencies and civilian authorities agree. The lethal anthrax attacks of fall 2001, including a death in Connecticut, show how easy it is to disperse anthrax spores with deadly effect."

Seven years ago, when former Defense Department Secretary William Cohen first ordered the mandatory anthrax inoculations for all 2.4 million people in the military, he based his decision on international threats, including Iraq's possession of anthrax spores supplied years earlier by a commercial U.S. biological laboratory.

Some weapons experts, however, say threats from abroad have been exaggerated and no evidence has ever been made public that any terrorist group worldwide, including al-Qaida, has ever successfully produced usable pathogenic anthrax spores.

Anthrax spores are effective because large quantities can be distributed through the air, and they last longer than many other biological agents. However, scientists say there are other biological agents as accessible and deployable as anthrax spores - the ricin and botulinum toxins among them. Also, weapons-grade anthrax is not easy to make or use, and variable winds make dispersing anthrax spores over a wide area problematic.

"The question is: Is anybody going to use anthrax as a weapon?" said Dr. Victor W. Sidel, co-author of the 2002 book "Terrorism and Public Health: A Balanced Approach to Strengthening Systems and Protecting People." "And if they do, we don't know what form of anthrax will be used. We don't know how anthrax materials will be modified or how they will be militarized."

He said the country needs to establish which proven diseases to work against, such as malaria, tuberculosis, AIDS, and which to disregard because they are being promoted for "a political reason" - comments echoed by John Richardson, a retired U.S. Air Force colonel who has contributed historical research on the anthrax vaccine to a federal lawsuit that blocked the military from ordering that military personnel be inoculated.

"Politicians only want to be able to say - in the aftermath of a terrorist event - that, `We did all we could do,'" Richardson said. "Defending against hypothetical bioterrorism deaths will bring in votes and contributions. The spending is driven by political expediency, not the threat.

"There is no magic shot that will immunize politicians from political consequences of terrorism," he said.

Licensing, Safety Issues

Under BioShield, the government has contracted with a biopharmaceutical company, VaxGen Inc., to produce 75 million doses of a new type of anthrax vaccine, called rPA102. The Washington Post reported in March that a setback in drug trials will prevent the company from meeting a November deadline to deliver the first 25 million doses into a national stockpile.

The only vaccine currently licensed for use, Anthrax Vaccine Adsorbed, made by BioPort Corp., requires a series of six shots before exposure: three initial doses at two-week intervals, followed by three additional doses at 6, 13 and 18 months. An annual booster is recommended.

The original license was granted for use against exposure to cutaneous anthrax, historically the most common - though still rare - form of the disease. People working with livestock are at risk of getting this type of anthrax through cuts or open sores.

Significant questions remain about the validity of using the vaccine for exposure to aerosolized spores - a scenario envisioned in a terrorist attack or on a battlefield. Critics of forced inoculations in the military argue that the vaccine has not been proved effective conclusively against inhaled spores in human or animal testing.

"To this day ... [the vaccine] has not been properly licensed for wide use against inhaled anthrax because of the pathetic level of evidence of safety, potency and efficacy," Connecticut Attorney General Richard Blumenthal said in a Dec. 30, 2005, court brief against forced inoculations in the military.

The U.S Food and Drug Administration disagrees. In reaffirming its licensing of the existing vaccine, the agency declared in December that "there are sufficient data from adequate, well-controlled clinical studies to assess the safety and effectiveness of AVA as a vaccine against anthrax infection regardless of route of exposure."

Six anonymous military employees mounted a legal challenge to mandatory vaccinations in the military, and a U.S. District judge last spring halted the mandatory inoculations. Voluntary inoculations have been allowed to continue. The Department of Defense has appealed the judge's ruling, but the appeals court sent it back to the trial judge for a reassessment.

BioPort says that contrary to criticism, its vaccine is proven and safe, and it has multiple government agencies to support it. The FDA and the Defense Department back it up, based on animal testing and data from past use on humans. The National Academy of Sciences Institute of Medicine released a report in 2002 that concluded the vaccine was acceptably safe and effective.

"Eighteen studies confirm the safety of BioPort's anthrax vaccine," the company says on its website. "Licensed for more than 30 years by the FDA, the safety profile of the anthrax vaccine is similar to that of the diphtheria and tetanus vaccines we give our children. ...

"Like with other vaccines, BioPort's anthrax vaccine may cause reactions in some individuals. Most of these reactions are limited to redness, itching and minor swelling at the site of injection; these events typically resolve in a matter of days."

The adverse reaction rate, once listed at 0.2 percent, is now listed at 5 percent to 35 percent.

The vaccine's package insert, warning doctors and vaccine users of possible, not proven, side effects, refers to unfavorable incidents reported to a national vaccine safety surveillance program called the Vaccine Adverse Event Reporting System, or VAERS. Though the program seeks to identify safety concerns, a VAERS listing does not prove that the reported malady was caused by the vaccination. Such events could have occurred coincidentally after vaccination.

From 1990 to 2001, more than 2 million doses of the vaccine were administered in the United States, followed by 1,850 reports to VAERS. About 6 percent of the reported events were listed as "serious." Such events include those that result in death, hospitalization, permanent disability or are life-threatening. Reports of fatalities included two sudden cardiac arrests, one myocardial infarction, one aplastic anemia, one suicide and one central nervous system lymphoma.

What About Antibiotics?

Potential injury from any vaccine alarms The National Vaccine Information Center, a private organization founded in 1982 by parents of children whose injuries or deaths were attributed to vaccinations.

Barbara Loe Fisher, president and co-founder of the center, suggested the country should sink its anthrax resources into treating people after an attack.

"Despite the fear and hysteria that has been created by physician health officials inside and outside of the Pentagon, there has not been one shred of evidence presented to the American people that biological weapons, including viable weaponized anthrax supplies, exist and are ready to be unleashed on the U.S.

"The wiser course may be to spend money to develop antidotes to anthrax exposure and have them ready to be dispersed at the first sign that there has been a real attack using weaponized anthrax," she said.

Inhalation of airborne anthrax can be treated after exposure by using antibiotics. The U.S. Department of Health and Human Services says that if there were a sizable anthrax attack on the civilian population now, the medical response would include antibiotics along with doses of the BioPort vaccine now in hand. The department says it has antibiotics to treat 40 million people.

The FDA acknowledges in its December ruling that antibiotic therapies are safe and effective in treating anthrax disease, and in the prevention of anthrax disease after exposure. It cautioned, however, that "long-term use of such therapies in individuals at high risk for anthrax disease, potentially for a period of years, has not been studied."

The FDA said the early stages of inhalation anthrax present flu-like symptoms, and a delay in a definitive diagnosis lessens the success rate for using antibiotics. In 2001, five of the 11 patients with inhalation anthrax died despite aggressive medical care, including antibiotic therapy, the FDA noted. The other six were treated and survived.

Protecting Vaccine Makers

A law passed by Congress in late December offers little comfort to people suspicious of mass vaccinations.

Unless a victim can prove willful misconduct, the law immunizes drug makers from lawsuits by people who become sick after they have been compelled to take a vaccine in a declared national health emergency.

The new law was designed to encourage drug makers to develop vaccines in preparation for a possible bird flu outbreak and other emergency situations, including biological attacks.

Sen. Bill Frist, R-Tenn., a force behind the law, said, "The bill strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible."

The law provides for a compensation fund covering serious injury or death, but opponents point out that it does not appropriate money for the fund.

Democratic Sens. Christopher J. Dodd of Connecticut and Edward Kennedy of Massachusetts were among those fighting the measure. In a combined press release, they said, "Without a real compensation program, the liability protection ... provides a Christmas present to the drug industry and bag of coal to everyday Americans."

Keeping An Eye On It All

Almost none of the biological warfare vaccine spending has been audited by various federal agency inspectors general or the U.S. Government Accountability Office, the watchdog for Congress, with the exception of an audit six years ago of multimillion-dollar defense spending to modernize the anthrax vaccine manufacturing plant in Lansing, Mich.

Blumenthal, Connecticut's attorney general, noted that government spending in this area has increased tremendously and said the Government Accountability Office ought to be called in.

"I believe there should be a searching GAO investigation, not only as to Department of Defense and BioPort Corp., but of all the costs surrounding [new] vaccine development," he said.

Said Blumenthal: "We also need a new, safer and updated vaccine. I think the government should help invest in a new vaccine, but also exercise control over what the company charges."

The head of BioPort last year urged policy makers to use caution when pursuing so-called next-generation vaccines. In Congressional testimony last July, BioPort President and CEO Robert G. Kramer called for "a multi-disciplined review" to consider vaccine proposals. "The risks of failure are too great and the cost of failure is too large to simply continue to operate in a vacuum," Kramer said.

His comments were echoed in December 2005 by Andrea Meyerhoff, former director of WMD Defense for the Department of Defense and former director of counterterrorism for the FDA.

"We must take steps to avoid the potential for flawed decisions because unproven countermeasures can be a waste of taxpayers' money, and worse, may not be safe and effective," Meyerhoff said. "Without oversight by an independent advisory oversight board, there is a real risk that an experimental, unproven countermeasure may be used in a bioterror attack, potentially resulting in unexpected side effects and failure to protect the public."